Trial Design Support

Trial Design Support

To promote the quality performance of imaging and radiotherapy (RT) in NCTN-sponsored clinical trials, IROC personnel provide QA-related support during every stage of research design and protocol development. Depending upon the level of imaging or radiotherapy (RT) a research plan calls for (from standard-of-care to novel techniques and new modalities), IROC offers services to match the project need, to include:

Consultation to investigators and protocol teams starting early on about appropriate modalities, techniques, and associated QA-related issues

Efficient and timely communication within the National Clinical Trial Network via teleconferences and face-to-face meetings

Implementation of a 3-tiered QA approach for RT facilities that tailors QA processes according to the complexity of a trial

Recommendations for local versus centralized image review for a given trial, along with identification of appropriate reader services

Support for the development of protocol sections describing proper image acquisition and RT techniques, along with corresponding QA processes

Resources focused on the timely development of accurate protocol content:

A library of templates to accelerate completion of the QA protocol components

The ultimate goal of IROC’s trial design support is the production of research protocols with clearly written imaging and RT specifications and QA requirements, which, in turn, will result in enhanced quality of the data submitted for analysis.

Trial Design Goal

The ultimate goal of IROC’s trial design support is the production of research protocols with clearly written imaging and RT specifications and QA requirements.